Effect of GnRH Agonist in FET (gnrh agonist)

June 12, 2026 updated by: Raafat Ahmed, Assiut University

Single Dose of Gonadotropin Releasing Hormone (GnRH)-Agonist as an Adjuvant Luteal Phase Support in Hormone Replacement Therapy (HRT) Frozen Embryo Transfer (FET) Cycles Prospective Comparative Study

To evaluate the impact of single dose GnRH agonist administration as luteal phase support on pregnancy outcomes in frozen ICSI cycle

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Assisted reproductive technologies (ART), particularly intracytoplasmic sperm injection (ICSI) with frozen embryo transfer, have significantly improved the outcomes of infertility treatment over the past decades. Despite these advances, implantation failure and suboptimal pregnancy rates remain important challenges. One of the critical factors influencing the success of embryo implantation is adequate luteal phase support, which ensures proper endometrial receptivity and maintenance of early pregnancy. (1_3) Progesterone supplementation has long been established as the standard method for luteal phase support in frozen ICSI cycles. It plays a fundamental role in transforming the endometrium into a receptive state suitable for embryo implantation and sustaining early gestation. However, despite its widespread use, pregnancy outcomes are not optimal in all cases, suggesting the need for additional or alternative therapeutic strategies to enhance reproductive success.(1_3) Recently, gonadotropin-releasing hormone (GnRH) agonists have gained increasing attention as a potential adjunct in luteal phase support protocols. It has been proposed that GnRH agonists may exert beneficial effects through multiple mechanisms, including stimulation of endogenous luteinizing hormone (LH) secretion, improved corpus luteum function, and enhanced progesterone production. Additionally, emerging evidence suggests a possible direct effect on the endometrium and embryo-endometrial interaction, which may further improve implantation potential.(4-7) Despite promising findings from several randomized controlled trials and meta-analyses, the role of GnRH agonists in luteal phase support remains controversial. Some studies have demonstrated improved implantation and clinical pregnancy rates, while others have reported no significant benefit compared to conventional progesterone therapy alone. This inconsistency is particularly evident in frozen ICSI cycles, where hormonal dynamics differ from fresh cycles.Therefore, further well-designed prospective studies are required to clarify the effectiveness of GnRH agonists in luteal phase support and to determine their potential role in improving reproductive outcomes

Study Type

Interventional

Enrollment (Estimated)

122

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Muslum
      • Asyut, Muslum, Egypt
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 1. Age 20-39 years 2. Undergoing HRT-FET cycle 3. ≥1 good quality embryo available , Gardner ≥3BB 4. Endometrial thickness ≥7mm on day of progesterone start 5. BMI 18-35 kg/m² 6. First or second FET cycle 7. Written informed consent

Exclusion Criteria:

  • 1. History of recurrent implantation failure ≥3 failed embryo transfers 2. Severe endometriosis Stage III-IV by ASRM 3. Uterine anomalies, submucous fibroid, or severe adenomyosis distorting cavity 4. History of recurrent pregnancy loss ≥2 consecutive 5. Contraindication or hypersensitivity to GnRH agonist 6. PGT-A cycles 7. Donor oocyte cycles

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard HRT protocol only. No additional injection
arm will not recieve any injection
Experimental: Standard HRT protocol + Triptorelin 0.1mg subcutaneous injection, administered once 30-60 minutes af
arm will recieve injection
Drug: GnRH agonist
women undergoing frozen ICSI cycles receiving progesterone + GnRH agonist for luteal phase support.
Other Names:
  • triptofem0.1 amp

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: basline
Presence of ≥1 gestational sac with fetal heartbeat on TVS at 6-7 weeks per embryo transfer.
basline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: basline
Number of gestational sacs / Number of embryos transferred x100
basline
Ongoing pregnancy rate
Time Frame: basline
Viable pregnancy ≥12 weeks gestation per ET
basline
Early miscarriage rate
Time Frame: basline
Pregnancy loss <12 weeks after clinical pregnancy diagnosed
basline
. Live birth rate per ET
Time Frame: basline
. Live birth rate per ET
basline
Side effects
Time Frame: basline
Injection site reaction, headache, vaginal bleeding
basline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Collaborators

Woman's Health University Hospital, Egypt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

June 12, 2026

First Submitted That Met QC Criteria

June 12, 2026

First Posted (Actual)

June 17, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • gnrh agonist ivf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information comments: https://pubmed.ncbi.nlm.nih.gov/?term=gnrh+agonist

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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